CN108433853A - A kind of novel more intensity multi-density sheaths - Google Patents

A kind of novel more intensity multi-density sheaths Download PDF

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Publication number
CN108433853A
CN108433853A CN201810311276.XA CN201810311276A CN108433853A CN 108433853 A CN108433853 A CN 108433853A CN 201810311276 A CN201810311276 A CN 201810311276A CN 108433853 A CN108433853 A CN 108433853A
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CN
China
Prior art keywords
conduit
sheath according
developing ring
proximal end
sheath
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN201810311276.XA
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Chinese (zh)
Inventor
王震
王成
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Zhejiang Batai Medical Technology Co Ltd
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Zhejiang Batai Medical Technology Co Ltd
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Priority to CN201810311276.XA priority Critical patent/CN108433853A/en
Publication of CN108433853A publication Critical patent/CN108433853A/en
Pending legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2210/00Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0096Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
    • A61F2250/0098Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The invention discloses a kind of sheaths of novel more intensity multi-densities, by distal area, body region and proximal end region composition;The distal area is made of the soft ends tip that high molecular material is constituted, and the body region collectively constitutes multi-layer braided type tube type by catheter outer, conduit braiding middle layer and conduit internal layer;The conical tubing that the proximal end region is made of single material.The present invention has novel structure, and excellent bending compliance, torsion and tubing intensity, concentricity is high, accurate positioning and using persistently effective, and has a variety of hardness and count in same tubing body, and guiding is more flexible in official jargon, and use scope is extensively etc..

Description

A kind of novel more intensity multi-density sheaths
Technical field
The present invention relates to medical instruments technical field, specifically a kind of novel more intensity multi-density sheaths.
Background technology
The interventions such as lumen distention object are effectively to treat and prevent human body official jargon closure and narrow medical instruments with implantation instrument.But Lumen distention object needs good loading parent and good protection and guiding could accurately reach lesion and in its expansion or releases Safety is withdrawn after putting.
The transport system of traditional lumen distention object by with minimally invasive or non-invasive guide function tip heads welding or glue It glues on inner pipe.This connection type has the risk that high tip heads and inner tube detach when in use, clinically also occurs The malpractice of many tip separation is complained, and FDA also discloses a large amount of cases recalled because of such risk;Such as 2013 4 Month FDA the event recalled etc. to U.S. Cook medical treatment COOK Zilver PTX bracket for eluting medicament.In addition, traditional pipe When will appear bending during use plastic deformation occurs for the design of the generally single material of transport system sheath of chamber expansion simultaneously The phenomenon that bending.Furthermore even if the transport system sheath of traditional lumen distention object is designed using the braiding structure of more materials Generally there is same shore intensity and same count, so appearance bending compliance is poor when in use, it is torsion poor and curved The problems such as bent blood vessel passability is poor.
The present invention provides a kind of a kind of sheath design of novel more intensity multi-densities for lumen distention object transport system, Sheath is with good compliance, torsional strength and axial strength, concentricity height, accurate positioning and using persistently effective and same There is a variety of hardness and count in one tubing body, there is excellent tube chamber adaptability.
Invention content
This invention address that providing a kind of with high-flexibility, high torsional strength, high-axiality and a variety of hardness and a variety of Density, high tube chamber adaptability, the loading sheath of release and the lumen distention object of accurate positioning.
The present invention uses following technical scheme:A kind of sheath of novel more intensity multi-densities, including conduit, catheter proximal end and Distal end of catheter, the conduit are helical structure by internal layer, middle layer and outer layer composition, the middle layer, or to be cross-woven Made of network, and density becoming larger from centre to both ends.
Further, the distal end of catheter includes the ends tip and developing ring;The ends tip are connected with developing ring by laser welding;It is aobvious Shadow ring connects with catheter fever plastic welding.
Further, the ends tip are frustum cone structure, and centre is provided with the axially extending bore being connected to the conduit, round platform knot It is welded with distal end developing ring the bottom surface of structure.
Further, development ring material in distal end is metal developing material, or is the high molecular material added with developer.Example Such as:It is made of pebax 6333 (80wt%) and BaSO4 (20wt%) mixing.
Further, the ends tip material is pebax (35D) or TPU.
Further, the internal layer material is PTFE materials, and kinds of interlayer is 304 stainless steel wires or dilval Silk, outer layer material are Nylon12 (72D).
Further, middle layer is helical structure, and the density WPI at both ends is 50-90, and intermediate density WPI is 5-25; Or for that can be cross-woven the network of composition, both ends braided wires are that mariages overlapping mariages weaves, and intermediate position is using single Silk overlapping monofilament braiding.Both ends count PPI is 2-5 times of middle braid density PPI.
Further, catheter proximal end includes proximal tube, is connected to the internal layer of conduit, and integrally formed;It is cased in proximal tube It is coated with pillar on the outside of proximal end developing ring, proximal tube and developing ring.
Further, proximal end developing ring is development tantalum metal material.
Further, the length of catheter proximal end is the 20% of whole sheath.
The technological merit of the present invention is high-flexibility, high intensity, high alignment, height release precision, excellent tube chamber adaptability. Multi-layer braided pipe provides high intensity and compliance for sheath, and a variety of braiding degree are compliance and the tube chamber adaptation for improving sheath Property.The soft ends tip are connected with sheath provides excellent tube chamber cruising ability and safety.
Description of the drawings
Fig. 1 is the structural schematic diagram of the embodiment of the present invention;
Fig. 2 is distal end of catheter structural schematic diagram;
Fig. 3 is catheter proximal end structural schematic diagram;
Fig. 4 is spiral interlayer structure schematic diagram;
Corresponding each toponym is numbered in figure is respectively:1- distal end of catheter, the ends 11-tip, the distal ends 12- developing ring, 2- are led Pipe, 21- internal layers, 22- middle layers, 23- outer layers, 3- catheter proximal ends, 31- pillars, 32- proximal tubes, the proximal ends 33- developing ring.
Specific implementation mode
The present invention relates to a kind of novel more intensity mostly braiding degree sheaths.The holder of the present invention is theoretically applied to any pipe Chamber is expanded in the transport systems of medical instruments or individually in the conduit system such as guiding, radiography.
The basic structure of the present invention is shown in Fig. 1, including conduit 2, catheter proximal end 3 and distal end of catheter 1, and the conduit is by internal layer 21, middle layer 22 and outer layer 23 form, and the middle layer 22 is helical structure (spring structure, as shown in Figure 4), or to intersect The cylindrical structure that the network of braiding is constituted, and density becoming larger from centre to both ends.Distal end is fine and close so that loads blood There is greater strength in the distal end of the body region 2 of enlargement of pipe object, so as to the more self-confident lesion by severe calcification in tube chamber; Intermediate region braiding it is sparse, so in the tube chamber with complicated bend circular arc have more preferably blood vessel compatibility, passability with Bendability.Wherein, helical structure makes it have good compliance and torsion.
The distal end of catheter 1 includes the ends tip 11 and distal end developing ring 12;The ends tip 11 and developing ring 12 by Laser Welding in succession It connects;Distal end developing ring 12 is welded with 2 thermoplastic of conduit.The ends tip 11 are frustum cone structure, and centre is provided with to be connected to the conduit 2 Axially extending bore, the bottom surface of frustum cone structure is welded with developing ring 12.To be uniformly distributed the shear stress that fluid is brought, reduce intravascular Resistance when guiding, while eliminating the blood vessel injury that sharp borders are brought;
Developing ring 12 material in distal end is metal developing material, or is the high molecular material added with developer.For example, by Pebax 633380wt% and BaSO420wt% mixing compositions.
Soft 11 material of the ends tip is soft flexible polymeric material, such as pebax35D or TPU, is reduced to blood vessel The injury of internal film tissue.
21 material of internal layer is PTFE materials, and 22 material of middle layer is 304 stainless steel wires or dilval silk, outer layer 23 materials are Nylon1272D.Middle layer 22 is helical structure, and the density WPI at both ends is 50-90, and intermediate density WPI is 5-25.Or middle layer 22 is that can be cross-woven the network of composition, both ends braided wires are that mariages overlapping mariages weaves, in Between position using monofilament overlapping monofilament braiding.Both ends count PPI is 2-5 times of middle braid density PPI.
Catheter proximal end 3 include proximal tube 32, be connected to the internal layer 21 of conduit the two it is integrally formed, material, structure are identical, closely Proximal end developing ring 33 is cased in end pipe 32, proximal tube 32 and 33 outside of developing ring are coated with pillar 31.Pillar 31 by FEP, PTFE, The equal heat-shrinkable materials of PALLADIUM " PEBAX " are constituted, preferably " PEBAX " this material, and pyrocondensation is in proximal tube 32 and developing ring 33 outsides, it is possible to reduce the interference stress that sheath curved bel comes eliminates harmful strain, improves the alignment of sheath;Compress tantalum gold Belong to ring on heat-shrink tube, not only strengthens the combination of pillar and proximal end ontology 32, but also improve the developability of sheath entirety.
The length of catheter proximal end 3 is the 20% of whole sheath, in favor of keeping balancing.
Based on the above structure, there is the hardness of 35D, body region 2 to have the 80D or so of a variety of braiding degree for sheath distal area 1 Hardness, proximal end region 3 add the hardness with 90D or so after proximal end pillar 31.A variety of hardness keep sheath safer, effective logical Cross tube chamber lesion.

Claims (10)

1. a kind of sheath of novel more intensity multi-densities, which is characterized in that including conduit (2), catheter proximal end (3) and distal end of catheter (1), the conduit is helical structure by internal layer (21), middle layer (22) and outer layer (23) composition, the middle layer (22), or For network made of interlacing, and density becoming larger from centre to both ends.
2. sheath according to claim 1, which is characterized in that the distal end of catheter (1) includes the ends tip (11) and developing ring (12);The ends tip (11) are connected with developing ring (12) by laser welding;Developing ring (12) is welded with conduit (2) thermoplastic.
3. sheath according to claim 2, which is characterized in that the ends tip (11) are frustum cone structure, and centre is provided with and institute The axially extending bore of conduit (2) connection is stated, bottom surface and the distal end developing ring (12) of frustum cone structure weld.
4. sheath according to claim 2, which is characterized in that distal end developing ring (12) material is metal developing material, or Person is the high molecular material added with developer.Such as:It is made of pebax 6333 (80wt%) and BaSO4 (20wt%) mixing.
5. sheath according to claim 2, which is characterized in that the ends tip (11) material is pebax (35D) or TPU.
6. sheath according to claim 1, which is characterized in that described internal layer (21) material is PTFE materials, middle layer (22) Material is 304 stainless steel wires or dilval silk, and outer layer (23) material is Nylon12 (72D).
7. sheath according to claim 1, which is characterized in that middle layer (22) is helical structure, the density WPI at both ends It is 5-25 for 50-90, intermediate density WPI;Or for that can be cross-woven the network of composition, both ends braided wires are overlapped for mariages Mariages weaves, and intermediate position is using monofilament overlapping monofilament braiding.Both ends count PPI is middle braid density PPI's 2-5 times.
8. sheath according to claim 1, which is characterized in that catheter proximal end (3) includes proximal tube (32), in conduit Layer (21) connection, and it is integrally formed;Proximal end developing ring (33) is cased in proximal tube (32), proximal tube (32) and developing ring (33) are outside Side is coated with pillar (31).
9. sheath according to claim 8, which is characterized in that proximal end developing ring (33) is development tantalum metal material.
10. sheath according to claim 1, which is characterized in that the length of catheter proximal end (3) is the 20% of whole sheath.
CN201810311276.XA 2018-04-09 2018-04-09 A kind of novel more intensity multi-density sheaths Pending CN108433853A (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112869922A (en) * 2020-12-31 2021-06-01 深圳市先健畅通医疗有限公司 Outer tube assembly, lumen device and conveyer
CN113332562A (en) * 2021-05-18 2021-09-03 常州瑞神安医疗器械有限公司 Multilayer braided sheath tube
CN116327461A (en) * 2023-03-23 2023-06-27 上海励楷科技有限公司 Double-layer braided support

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5807350A (en) * 1995-11-03 1998-09-15 Cordis Corporation Kink resistant catheter sheath introducer
JP2002272852A (en) * 2002-01-08 2002-09-24 Terumo Corp Catheter for cerebral artery and catheter instrument
JP2004215689A (en) * 2003-01-09 2004-08-05 Jiima Kk Catheter for angiography
JP2006149442A (en) * 2004-11-25 2006-06-15 Piolax Medical Device:Kk Catheter
US20070185558A1 (en) * 2006-01-18 2007-08-09 William A. Cook Australia Pty. Ltd. Endoluminal delivery device
CN201782744U (en) * 2010-08-30 2011-04-06 武汉佑康科技有限公司 Soft and hard combined bendable turning endoscope
CN202236789U (en) * 2011-09-09 2012-05-30 方亦斌 Head end camber changeable medical pipe for radiography pipe and microcatheter
CN204352347U (en) * 2014-12-09 2015-05-27 孙小薇 Stagewise flexible gradual change blood vessel microtubular
CN204364624U (en) * 2015-01-07 2015-06-03 北京国械堂科技发展有限责任公司 Ureter guiding sheath
CN104707235A (en) * 2013-12-17 2015-06-17 常州乐奥医疗科技有限公司 Novel micro-catheter
CN105105894A (en) * 2015-07-20 2015-12-02 宁波琳盛高分子材料有限公司 Reinforced compound sheathing canal, preparation method and application thereof
CN105311730A (en) * 2014-07-31 2016-02-10 微创神通医疗科技(上海)有限公司 Guiding catheter
CN105664338A (en) * 2016-04-26 2016-06-15 业聚医疗器械(深圳)有限公司 Balloon catheter
CN206424410U (en) * 2016-11-09 2017-08-22 南京微创医学科技股份有限公司 A kind of seal wire of measurable narrow segment length

Patent Citations (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5807350A (en) * 1995-11-03 1998-09-15 Cordis Corporation Kink resistant catheter sheath introducer
JP2002272852A (en) * 2002-01-08 2002-09-24 Terumo Corp Catheter for cerebral artery and catheter instrument
JP2004215689A (en) * 2003-01-09 2004-08-05 Jiima Kk Catheter for angiography
JP2006149442A (en) * 2004-11-25 2006-06-15 Piolax Medical Device:Kk Catheter
US20070185558A1 (en) * 2006-01-18 2007-08-09 William A. Cook Australia Pty. Ltd. Endoluminal delivery device
CN201782744U (en) * 2010-08-30 2011-04-06 武汉佑康科技有限公司 Soft and hard combined bendable turning endoscope
CN202236789U (en) * 2011-09-09 2012-05-30 方亦斌 Head end camber changeable medical pipe for radiography pipe and microcatheter
CN104707235A (en) * 2013-12-17 2015-06-17 常州乐奥医疗科技有限公司 Novel micro-catheter
CN105311730A (en) * 2014-07-31 2016-02-10 微创神通医疗科技(上海)有限公司 Guiding catheter
CN204352347U (en) * 2014-12-09 2015-05-27 孙小薇 Stagewise flexible gradual change blood vessel microtubular
CN204364624U (en) * 2015-01-07 2015-06-03 北京国械堂科技发展有限责任公司 Ureter guiding sheath
CN105105894A (en) * 2015-07-20 2015-12-02 宁波琳盛高分子材料有限公司 Reinforced compound sheathing canal, preparation method and application thereof
CN105664338A (en) * 2016-04-26 2016-06-15 业聚医疗器械(深圳)有限公司 Balloon catheter
WO2017185705A1 (en) * 2016-04-26 2017-11-02 业聚医疗器械(深圳)有限公司 Balloon catheter
CN206424410U (en) * 2016-11-09 2017-08-22 南京微创医学科技股份有限公司 A kind of seal wire of measurable narrow segment length

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN112869922A (en) * 2020-12-31 2021-06-01 深圳市先健畅通医疗有限公司 Outer tube assembly, lumen device and conveyer
CN112869922B (en) * 2020-12-31 2023-08-25 先健科技(深圳)有限公司 Outer tube assembly, lumen device and conveyor
CN113332562A (en) * 2021-05-18 2021-09-03 常州瑞神安医疗器械有限公司 Multilayer braided sheath tube
CN116327461A (en) * 2023-03-23 2023-06-27 上海励楷科技有限公司 Double-layer braided support

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